The EMA has concluded a class review of bisphosphonates, adopted a number of positives opinions for new medicines and revealed more about the ongoing studies regarding GlaxoSmithKline's Pandemrix pandemic influenza vaccine and a possible link with narcolepsy.
GlaxoSmithKline (GSK) identified certain over-the-counter (OTC) brands in its consumer healthcare business that the company plans to divest.
The US patent laws are undergoing a major revision, the first large revision since the Patent Act of 1952.
Axcan acquires Mpex Pharmaceuticals; Bend Research receives patent for improving bioavailability of low-solubility drugs; and More.
On Apr. 18, 2011, scientists from the national laboratories of five African nations gathered in Accra, Ghana, to take part in a week of technical training put on by the US Pharmacopeia (USP) that will teach them how to detect substandard and counterfeit medicines.
FDA Released Draft Guidance for Industry on Safety Labeling Changes.
On Tuesday, Apr. 19, 2011, officials from FDA, the US Department of Health and Human Services, and the Drug Enforcement Administration introduced President Obama?s plan for curbing prescription-drug diversion and abuse.
The implementation of digital photomicrography has expanded the capabilities of microanalysis for quality control. But if used incorrectly, the technique can hurt more than help.
We want to fill one of our oxygen-sensitive products inside an isolator system. Can we run an isolator with pure nitrogen and defined humidity?
PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the April 2011 edition from ACS Valves and L.B. Bohle.
To find out how well industry is applying QbD, and what benefits the approach can bring, Equipment and Processing Report talked to Moheb M. Nasr, director of FDA?s Office of New Drug Quality Assessment.
Alynlyam forms drug-delivery pact with the University of British Columbia; Linda S. Mayer Joins Schott North America; and More.
FDA recently published guidance for preventing the cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients with nonpenicillin beta-lactam antibiotics.
Merck & Co. has formed a joint venture with the Mumbai-based specialty pharmaceutical company Sun Pharmaceutical Industries to develop, manufacture, and commercialize new combinations and formulations of branded generic drugs in emerging markets.
FDA Released Draft Guidance for Industry on Safety Labeling Changes.
Nearly 900 therapies for the treatment, diagnosis or prevention of cancer are currently in development, according to a report released by PhRMA.
Johnson and Johnson (J&J) has agreed to pay more than $77 million after being charged for violations of the US Foreign Corrupt Practices Act, which include bribing public doctors in several European countries and paying kickbacks to illegally obtain business in Iraq.
New Web Search Feature on FDA.gov, Search for Product Recalls More Quickly
Johnson & Johnson has instituted a new structure for its Consumer Group according to a Reuters report.
After completing a strategic review of options for its Capsugel business, Pfizer announced on Apr. 04, 2011 that Kohlberg Kravis Roberts & Co L.P will acquire the pharmaceutical and dietary capsule company.
The Society of Chemical Manufacturers and Affiliates criticized the Secure Chemical Facilities Act, which would require chemical facilities to use inherently safer technology as part of chemical-site security measures.
sanofi-aventis has gained full control over Genzyme, bringing the much talked about acquisition deal between the two companies to a close.
ATMI Forms Distribution Pact with Finesse; AAIPharma Promotes Dean Shirazi; and More.
The Women in the World Summit, which was held in New York in March, focused on issues and solutions for improving the economic, political, and social rights of women globally, including a focus on global health initiatives.
Eli Lilly and GlaxoSmithKline are among several pharmaceutical companies using technology transfer as way to improve health outcomes in the developing world.
This article, which focuses on manufacturing and drug access, is Part II of a three-part series on biopharmaceutical issues in public health, government, and developing world markets.
A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.
PRTM helps to improve supply-chain management and logistics in developing countries.
Research and development may be headed for divorce.